K053491 is an FDA 510(k) clearance for the PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Penumbra, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 27, 2006, 133 days after receiving the submission on December 15, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K053491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2005 |
| Decision Date | April 27, 2006 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |